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Regulatory Affairs and Validation Videos & On-Demand Webinars


Listen and watch our regulatory affairs and validation webinars to learn about the latest technologies, experimental tips and troubleshooting strategies for your processes.

The Role of BPOG Extractables Data in the Effective Adoption of Single-Use Systems

Nov | 2017
  • Presenter: Satish Kumar Mohanvelu, Marketing Manager, Emprove® Program; and Jessica Shea, E&L Global Technical Services Manager, BioReliance® End-to-End Solutions
  • Abstract
    The successful adoption of single-use technologies in a biopharmaceutical process largely relies on confidently selecting the right components for use in the fluid path of a product, within a specific process. An important step in choosing such components requires generating an extractables profile, which can be done by carefully selecting the solvent streams and extraction conditions to model the product and process steps complemented with the right analytical strategy.

    In this webinar, you will learn:
    • An approach to adopt the BioPhorum Operations Group (BPOG) extractables protocol as a baseline testing strategy.
    • How to apply extractables data to a specific process followed by a systematic, risk-based safety assessment approach used for comparing known safety concern thresholds.
    • The important stages in the risk assessment process as demonstrated by case studies from typical drug manufacturing processes where single-use components were used.


Vaccine Cell Bank and Virus Seed Characterization

Oct | 2017
  • Presenter: Martin Wisher, Senior Director, Global Head of Regulatory Affairs, BioReliance® Services
  • Abstract
    This webinar will present regulatory requirements for cell bank and virus seed characterization from different organizations worldwide. Learn about new technologies for determination of cell substrates & virus seed stocks and detection of agent contamination.

    The characterization of cell substrates, virus seed stocks and virus harvests, used in human vaccine production, for identity and purity is required by regulators worldwide. This presentation will give you an overview of the regulatory requirements given in the latest guidance documents from the US FDA, WHO, European Pharmacopoeia and ICH. It will highlight differences between these documents and describe new technologies for determining the identity of cell substrates and virus seed stocks as well as detecting adventitious agent contamination.

    In this webinar, you will learn:
    • about the importance of characterising cell banks and virus seed stocks in order to meet worldwide regulatory requirements.
    • the difference between guidance documents from different organizations worldwide
    • new technologies for determining the identity of cell substrates and virus seed stocks
    • detecting adventitious agent contamination


Viral Risk Mitigation Strategies: Key Considerations in the Prevention and Detection of Viral Contamination

Sept | 2017
  • Presenter: Alison A. Armstrong, PhD, Senior Director, Global Head of Field Development Services
  • Abstract
    Regulatory guidelines have defined industry best practices around adventitious virus contamination and risk mitigation in terms of patient safety.

    Today, the industry is taking a closer look at minimizing the business risk associated with viral contamination and is taking a more directed view of risk mitigation. This approach includes virus prevention and detection, in addition to removal.

    From cell culture seed train to final fill vial, this presentation will describe:
    • Potential risks associated with different areas of biotech processes
    • What can be done to minimize adventitious virus risk in those areas.
    The overarching strategy of risk mitigation will include evaluation of raw materials, modified expression systems, environmental controls, upstream and downstream processing, as well as testing and regulatory considerations.


Quality by Design (QbD) for Virus Filtration

Aug | 2017
  • Presenter: Jeffrey Hartnett, Senior Product Manager - Virus Safety Solutions
  • Abstract
    Learn how QbD principles can be applied to understand the critical processing and feed parameters affecting virus retention, allowing the development of a streamlined validation approach and robust process control strategy for virus clearance via filtration.

    ICH Q8 defines Quality by Design (QbD) as “…a systematic approach to development that begins with predefined objectives and emphasizes product and process understanding and process control, based on sound science and quality risk management.” Within the context of virus clearance for bioprocesses, QbD principles can be applied to understand the critical processing and feed parameters affecting virus retention, guiding the development of a streamlined validation approach and robust process control strategy for virus clearance unit operations. We will explore how QbD principles can be applied to downstream virus filtration of mAbs and recombinants, explore the application of these principles within the framework of the Viresolve® Pro Device (parvovirus retentive filter) and outline the benefits that can be gained through simplifying the validation strategy and increasing the robustness of your regulatory filing package.

    In this webinar, you will learn:
    • How to simplify validation study design
    • Identify critical process and feed parameters affecting virus retention
    • How to compile a robust regulatory filing package


Genotoxicity Solutions for Tobacco Products and Medical Devices

July | 2017
  • Presenter: Aparajita Dutta, Senior Scientist and Study Director
  • Abstract
    In this webinar we will discuss the regulations that govern tobacco products and medical devices. We will cover the assays available, options and testing paradigms to ensure your products are safe and will be accepted by the regulatory bodies.

    New regulatory guidelines have recently been introduced for both tobacco products and medical devices. For tobacco products, while many questions remain about the testing required for regulatory approval, BioReliance has designed a program that will provide valuable information about the safety, hazard, and genotoxicity of each type of regulated tobacco product. In regards to medical devices, BioReliance has received its certification and compliance for medical device testing. To comply with regulations and ensure the safety of your devices, BioReliance has designed a testing program specifically for you that includes all the required and desired testing options.

    In this webinar you will learn:
    • The assays required for regulatory submission of tobacco products
    • The options available for testing tobacco products and how to successfully bring your products to market
    • The assays required for regulatory submission of medical devices
    • The options available for testing medical devices and how to successfully bring your products to market


Challenges and Options in High Viscosity Tangential Flow Filtration

April | 2017
  • Presenter: Dr. Paul Beckett, Technology Manager Life Sciences, EMEA
  • Abstract
    Overview of available TFF solutions for achieving high viscosity of monoclonal antibodies and plasma IgG, and strategies for reliable cycle-to-cycle cleaning.

    Current trends in the bioprocessing industry are driving mAb and plasma producers to formulate at higher protein concentrations. As a result, formulating using tangential flow filtration (TFF) may be limited in reaching these concentrations due to high pressures caused by highly viscous feed streams. Filtration devices used during processing have to be optimized in order to handle both high viscosity and pressures while maintaining high flux and excellent product recovery.

    In this webinar, we will review a recent study in which a family of filtration devices was evaluated to characterize the impact of membrane material and channel geometry on process performance and cleanability when working with high concentration feed streams. The results show the performance of each filtration device over multiple re-uses and presents a solution that can overcome process limitations due to high viscosity formulations.

    In this webinar you will learn:
    • Options to achieve higher concentration
    • Cleaning recommendations for TFF cassettes used in high viscosity feedstreams
    • Performance comparison between device design in TFF cassettes


Transitioning Chemical Specialties from Clinical to Commercial in Small Molecule Drug Synthesis

March | 2017
  • Presenter: Brigitte Mangiarotti, Head of Quality Services - Research Solutions & Gero Nordmann, Director Pharm Materials - Process Solutions
  • Abstract
    In this webinar, we will explore best practice approaches for seamless handover at critical junctures en route to commercial manufacturing of small molecule drugs.

    One of the biggest challenges in today's small molecule drug development are the different requirements on quality and supply chain going from exploratory research to commercial manufacturing. A key risk to consider is the over- and/or underengineering of chemical specialties for drug synthesis leading to higher total cost of ownership. This webinar will cover critical aspects to consider in order to make the best choices when transitioning from clinical to commercial phases.

    In this webinar you will learn:
    • To understand raw materials pitfalls in transitioning to a commercial small molecule drug manufacturing process
    • To understand cost implications of raw materials choices
    • To get an overview of the changing regulatory landscape


Biosimilars As A Nice Cake. But Why Would You Share Your Cake?

March | 2017
  • Presenter: Guillaume Plane, Management and Development Manager, Merck
  • Abstract
    The Webinar will focus on what should be considered in order to make the best choice to develop one given biosimilar instead of another. Secondly, we will consider the main requirements to be successful in delivering such a biosimilar on the market.

    With patents expiring on many established big biologic drugs, biosimilars have become increasingly tantalizing opportunities for manufacturers over the past ten years. The Webinar will focus on what should be considered in order to make the best choice to develop one given biosimilar instead of another. Secondly, we will consider the main requirements to be successful in delivering such a biosimilar on the market.

    In this webinar you will learn:
    • Why and how to prioritize between biosimilars in development
    • How to be successful in developing a biosimilar
    • How to be successful in launching a biosimilar on the market


Bioprocessing Raw Materials: Risk Mitigation Strategies

Feb. | 2017
  • Presenter: Chandana Sharma, Head of Cell Culture Raw Materials, Upstream R&D, Merck
  • Abstract
    Variability is inherently introduced by bioprocessing raw materials. A detailed initiative to fully characterize raw materials using orthogonal techniques can provide assurance that the raw materials are as fit for purpose as possible. This approach also acts as a thorough risk mitigation step. Our raw material characterization program is an initiative taken as a direct result of biopharmaceutical customers' feedback. The initiative focuses on developing unique tests to ensure functionality of the raw material that ultimately influences supply chain and procurement decisions. 

    In this webinar you will learn: 
    • Approaches to develop a risk mitigation program 
    • Methods of characterizing biopharma raw materials 
    • Variability in biopharma raw materials 


Challenges and Successes in Externalization of the ADC Supply Chain

Feb. | 2017
  • Presenter: Jyothi N. Swamy, Ph.D.
  • Abstract
    Presentation Title: MANAGING COMPLEX ADC PROJECTS IN A GLOBAL ENVIRONMENT

    Finding a contract manufacturing partner for the development and commercialization of key intermediates, complex small-molecule APIs and biologic drug substances shouldn’t be such a headache. The uniqueness, versatility, and complexity involved in each project only means you need to make sure you’re asking the right questions before putting your trust in a CMO. A transparent supply chain is only part of the solution. You’ll need a partner that has an in-depth understanding of the project needs and global project management expertise. Join Jyothi Swamy as she covers all the critical components required for a mutually beneficial partnership that paves the way for a high quality, streamlined, comprehensive, and collaborative solution for the production of ADCs—from development of conjugate, linkers, payloads, drug product fill finish from clinical supplies to commercial drug product.


Overcoming Quality and Regulatory Challenges of Implementing Single-Use Pharmaceutical Manufacturing

Feb. | 2017
  • Presenter: Janmeet Anant, Ph.D., Regulatory Advocate
  • Abstract
    Single-use pharmaceutical manufacturing has been widely adopted in development and clinical manufacturing. Even though these disposable technologies offer various benefits, there are still some challenges based on a lack of standardization of quality tests and procedures.

      In this webinar you will learn: 
    • Current and upcoming industry and regulatory requirements for single-use pharmaceutical manufacturing systems 
    • Detailed compatibility requirements, incl. extractables/leachables, particulates, integrity and supplier change control standard proposals 
    • Quality and regulatory documentation based on these requirements, making the implementation of single-use systems more efficient 


Review of a Supplier's Quality Control while Manufacturing Single-Use Systems

Nov. | 2016
  • Presenter: Michael Felo, Director Mobius Single-Use, Merck
  • Abstract
    Single-Use systems, enabling faster more cost effective bio-pharma manufacturing, must also meet high quality parameters and standards while conducting component qualification, manufacturing operations, inprocess testing, and final product release.

    For single use systems, quality control during the manufacturing process is critical. In a traditional stainless-steel system, the end user has significant control over the design, construction, qualification and validation, and maintenance of the system. When implementing a single-use system, the supplier of the single use product takes responsibility for many of these functions from the user. It is therefore important that the single use supplier has established and follows a strong quality control system. This presentation will highlight the quality systems, processes, facilities, and personnel required to assure the performance, robustness, and sterility of single use systems.

    In this webinar you will learn:

    • The process used to qualify components, suppliers and sub-suppliers
    • Managing documentation control, change control, process particulate control, risk mitigation practices
    • See examples of Extractables Testing, Validation of MFG processes, MFG Controls, Sterilization Qualification, Realease Testing and Certification, Integrity Assurance


Processing of Small Biological Molecules by TFF

Nov. | 2016
  • Presenter: Emily Peterson, Biomanufacturing Engineer, Merck
  • Abstract
    Strategies to overcome key limitations and challenges such as higher molecular osmotic pressure and lower membrane permeability when customizing small molecule (3-10 kDa) TFF processing.

    Due to their higher osmotic pressures and mass transfer coefficients, small molecules in the range of 3 – 10 kDa, like insulin, often require unique processing conditions as compared to those of larger molecules. TFF processing strategies developed for larger molecule applications may not be appropriate and can lead to an increase in process variability and sub-optimal performance.

    This webinar explores:

    • The key limitations and challenges typically observed with small biological molecule TFF processing
    • Explains the strategies required for optimal success with your TFF step


Aseptic Process Sampling Risk Mitigation - A Regulatory Perspective

Oct. | 2016
  • Presenters:
    • Janmeet Anant, Regulatory Advocate, Merck
    • Marc-Antoine Kaag, Global Product Manager, Sampling, Merck
  • Abstract
    Increasing validation requirements along with the raise of QbD and PAT have put sterile processes sampling under scrutiny by regulation bodies. Traditional sampling methods have reached their limits whilst closed sampling methods come of age.

    Beyond the necessity to ensure contamination control, the regulatory authorities require compliances in different aspects related to the sampling method of a drug. This webinar will review the benefits attained from implementing single-use systems. In this objective, these authorities provide guidance on processes helping to reach these requirements (e.g. QbD, PAT, Process validation). Drug manufacturers have the possibility to respond to these expectations through the implementation of single-use systems, instead of common traditional sampling methods, which include usage of glass bottles or SIP stainless steel valves.

    Join this webinar to learn more about the recommendations and requirements stated by these major regulatory authorities around the monitoring of the manufacturing process with the execution of sampling. In addition, this webinar will include a review on the benefits attained from implementing single-use systems, therefore reducing the sampling risks compared to traditional methods.

    In this webinar you will learn:

    • Key drivers for Aseptic Process Sampling
    • Complexity and Risks of "Traditional" Sampling Methods
    • Regulatory Recommendations, Corresponding Needs, and how to get there


Current Regulatory Expectations and Technical Advances in the Quality Control of Biological Medicinal Products

Sept. | 2016
  • Presenter: Dr. Alison Armstrong, Senior Director, Global Head of Field Development Services, Merck
  • Abstract
    The requirements for the quality control (QC) of biological medicinal products are defined in guidance documents produced by regulatory agencies and international organisations such as EMA, US FDA, Japanese PMDA, ICH and WHO. Although these guidance documents are revised periodically, these revisions usually lag behind scientific advances and technical innovations.

    This webinar will describe a number of topics in the areas of cell line characterization and bulk harvest testing for contaminants where new technical innovations are occurring. The regulatory response to these developments will be discussed.

    Topics that will be covered include:

    • Current and new approaches to genetic stability and clonality determinations
    • New approaches to cell line identity testing
    • Spiroplasma testing
    • Evaluation of in vitro and in vivo assays for extraneous agent detection and replacement of in vivo assays
    • Recommendations for the virus evaluation of Investigational Medicinal Products (IMPs) from EMA and US FDA


Excipient GMP: The Industry Journey from Guides to Standards

July | 2016
  • Presenter: Bretta Lichtenhan, Surveillance and Advocacy Regulatory Affairs Expert, Merck
  • Abstract
    Excipient GMP has evolved over the past ten years from guides to standards. The focus on the importance of excipient GMP is ever increasing. In March 2016, the European Guidelines on formalized risk assessment for ascertaining the appropriate GMP for excipients of medicinal products for human use became official. It is clear that regulatory bodies see the value in having the drug manufacturers understand and assess the risk of the excipients in their drug products as it relates to appropriate GMP.

    As an excipient supplier our organization understands the regulatory framework and the needs of our customers as they relate to excipient GMP.

    During this webinar you will learn about the evolution of excipient GMP from guides to standards. A review of the current excipient GMP standards will be covered; specifically, it will include an explanation of what the EXCiPACT™ certification scheme is and how it includes a standard for excipients. Additionally, a review of the currently published NSF/IPEC/ANSI 363 GMP excipient standard will be covered. Lastly, we’ll discuss and review our approach for providing Emprove® documentation to support our customers.


Guideline on Elemental Impurities: Challenges and Approaches for Implementation

June | 2016
  • Presenter: Dr. Ulrich Reichert, Regulatory Management, Life Science, Merck
  • Abstract
    In June 2016, the ICH Q3D guideline on elemental impurities will become effective for new drug products. Elemental impurities may arise from elements that have been added intentionally, or that may be present as contaminants. The guideline has a huge impact on the control strategy of metal and other inorganic impurities for drug products worldwide.

    This webinar provides an overview of the current and upcoming regulatory requirements for elemental impurities, including recent developments in the pharmacopoeias (Ph. Eur. and USP). We will discuss their impact on drug product and pharmaceutical starting materials, focusing on APIs and excipients. The presentation will also outline risk-based approaches to assess and implement control strategies for elemental impurities, based on the latest regulatory requirements, and how this can be supported with dedicated documentation.


Risk Based Assessment of Sterilizing Grade Filters

June | 2016
  • Presenter: Janmeet Anant, Regulatory Advocate, Merck
  • Abstract
    Drug manufacturers worldwide conduct risk assessments to identify suitable materials and consumables for their manufacturing processes. Complex single-use manufacturing systems have started to be implemented in higher risk aseptic processing applications, such as the final sterile filtration step after formulation of the drug substance.

    Regulatory authority guidance highlights that "Any effects of the filter on the product should be described" (FDA, "Guidance for Industry for the Submission Documentation for Sterilization Process Validation in Applications for Human and Veterinary Drug Products", 1994) and "The filter should not affect the product by removal of ingredients from it or release of substances into it" (European Commission, EUDRALEX Volume 4, "Good Manufacturing Practices, Medicinal Products for Human and Veterinary Use", Annex 1, "Manufacture of Sterile Medicinal Products", 2008). In addition, the PDA Technical Report 26 provides more details on proposed studies of the sterile filtration of liquid drug products, which is endorsed by regulators.

    This webinar will offer insight into current and upcoming industry and regulatory requirements for filters, such as more detailed compatibility and extractables data. In addition, a review of single-use filter quality and regulatory documentation based on these requirements will be covered, which will make risk assessments, based on ICH Q9 guidance, more efficient for the sterile drug product manufacturer.


Facilitate Risk Assessment for Excipients with Emprove® Documentation

March | 2016
  • Presenter: Dr. Erhard Lührs, Manager, Emprove® Pharm Chem Solutions, Merck
  • Abstract
    On March 21, 2015, the EU Commission published its new guideline on formalized risk assessment for excipients, which aims to ensure the quality and traceability of pharmaceutical excipients. Risk assessments to ascertain the appropriate good manufacturing practice for excipients used in authorized medicinal products for human use now need to be carried out by March 21, 2016.

    As of this date, authorized manufacturers are required to complete a documented risk analysis for all excipients they use in marketed formulations. We will support pharmaceutical companies in this process by providing them with a complete package of information to facilitate their risk assessment.

    The webinar will explore:
    • The EU risk assessment guideline for excipients
    • Suppliers' and pharmaceutical companies' roles and responsibilities in the risk assessment process
    • The Emprove® Program: New regulatory documentation that supports a risk-based approach


Formalized Risk Assessment: Challenges and Best Practices

Oct. | 2015
  • Presenter: Frithjof Holtz, Head of Advocacy and Surveillance Global Regulatory Management, Merck KGaA, Darmstadt, Germany
  • Abstract
    Drug manufacturers worldwide conduct risk assessments to identify suitable materials and consumables for their manufacturing processes. Europe is the first region to formalize this practice since the EU Commission published a guideline on "the formalized risk assessment for ascertaining the appropriate good manufacturing practice for excipients of medicinal products for human use (2015/C 95/02)", in March 2015. As a result, pharmaceutical manufacturers not only have to perform a formalized risk assessment, but also are required to verify the appropriate GMP for excipients. It is important to note that the requirement also applies to companies outside the EU, selling products to EU.

    This webinar will offer insight into the EU Commission’s risk assessment approach to excipient quality and the challenges that can be overcome. Furthermore it will provide practical considerations and best practices to support risk assessment activities, closing with perspectives on potential approaches for consumables in the pharmaceutical manufacturing process.


New Guideline on Elemental Impurities and its Implication

March | 2015
  • Presenter: Ulrich Reichert, Global Regulatory Management, Merck
  • Abstract
    The International Committee on Harmonization (ICH) has recently published the guideline ICH Q3D to control elemental impurities. This new guideline will have a huge impact on the control strategy of metal and other inorganic impurities for drug products worldwide. Elemental impurities may arise from elements that have been added intentionally, or that may be presents as contaminants. This webinar provides an overview of the current and upcoming regulatory requirements (ICH Q3D, USP, EMA-Guideline) and will outline the scope of the current regulation on elemental impurities. The impact on drug product and pharmaceutical starting materials will be discussed and the control strategies of ICH, USP and the existing EMA guideline will be compared. A risk based approach for assessment and control of elemental impurities will be suggested to cover the new regulation.


Defining a Strategy for the Validation and Qualification of Sterile Filtration Processes for Investigational Medicinal Compounds

Feb. | 2015
  • Presenters: Janmeet Anant, Regulatory Advocate and George Adams, Director of Marketing for Provantage® Laboratory Services, Merck
  • Abstract
    Investigational New Drug (IND) applications must contain information allowing an assessment of whether or not the product is reasonably safe for initial testing in humans. This typically includes information pertaining to the chemical composition, manufacturing methods, stability, and controls used for manufacturing the drug substance and the drug product. Providing this information for investigational medicines can be more complex where the manufacturing process may not yet be fully defined. Sterilizing filtration should be qualified during early clinical phases to demonstrate that it is effectively providing a sterile product without adversely affecting its properties. The filter, as critical equipment used for manufacturing sterile phase 1 investigational drug, should not contaminate or otherwise react with, add to, or be absorbed by the drug. In order to assess its performance and thereby ensure the quality of the product, several aspects have to be examined including bacterial retention, chemical compatibility, extractables and adsorption. Based on our experience at Merck, you will learn about the key elements of sterile filtration validation, along with understanding more about global regulatory guidance for developmental phase drug products.


Quality Agreements for Pharma Raw Materials: Update and Current Practice

Dec. | 2014
  • Presenter: Michaela Marx, Regulatory Affairs Manager, Merck
  • Abstract
    Quality agreements are legally binding documents agreed between the quality assurance departments of the contractual parties – in most cases, between the pharmaceutical's manufacturer and its supplier and/or contract manufacturer. Their intention is to delineate the two parties' quality-related responsibilities with regard to manufacture, testing and supply of pharma raw materials. Moreover, there are also a number of legal issues to be considered. Regulatory authorities are also strengthening their requirements for quality agreements, as these have become an important part of supplier qualification. In 2013, the FDA issued draft guidance describing its expectations, entitled "Contract Manufacturing Arrangements for Drugs: Quality Agreements". The revised Chapter 5 (‘Manufacturing’) of the EU GMP Guide requires the conclusion of quality agreements between the pharmaceutical manufacturer and its suppliers for pharmaceutical starting materials, defining quality-related aspects for the starting materials with regard to production, control and distribution. Everyone who has ever negotiated a quality agreement knows that this can be a time-consuming job. In this webinar we will discuss what should be considered for pharma raw materials taking into account expectations by regulatory authorities. Pragmatic approaches in order to reduce negotiation time e.g. by using templates offered by industry associations will also be outlined.


FDASIA - Food Drug Administration Safety and Innovation Act

June | 2014
  • Presenter: Bretta Lichtenhan, Regulatory Surveillance and Advocacy, Merck
  • Abstract
    The Food and Drug Administration Safety and Innovation Act, also known as FDASIA, was signed into law on July 9th 2012 and became effective on October 1st.

    This strengthens the FDA’s ability to safeguard and advance public health by (as reiterated from the FDA’s website):

    • Giving the authority to collect user fees from industry to fund reviews of innovator drugs, medical devices, generic drugs and biosimilar biological products
    • Promoting innovation to speed patient access to safe and effective products
    • Increasing stakeholder involvement in FDA processes
    • Enhancing the safety of the drug supply chain Two main aspects of FDASIA are covered that affect API and excipient supplier’s businesses: Title III (GDUFA), and title VII (The Drug Supply Chain).

    What is GDUFA?
    GDUFA stands for the Generic Drug User Fee Amendments. Two kinds of fees within GDUFA affect API and excipients suppliers: DMF fees and API facility fees. Suppliers must pay the DMF fees upon a customer’s incorporation of an API DMF into their ANDA registration.

    This fee is a one-time only fee. However, suppliers also pay yearly fees in the form of API facility fees. Title VII, also known as the Drug Supply Chain section of the Act, pertains to APIs, Excipients, and Generic drugs alike. This provision may eventually require Identification of drug excipient information with product listing. To date, no such guidelines have been given in this aspect. However, API and excipient suppliers may eventually have to provide drug companies the following requested information for APIs and excipients: Location, Point of contact, Email address, and Unique facility identifier. As it currently stands, the generic drugs companies must create a Unique identifier designated by FDA to assign, monitor, and track inspections of their regulated firms. Guidelines, proposed rules, public meetings and yearly reports continue to be published by the FDA with respect to the many aspects of FDASIA. A relevant overview of these topics is covered in the presentation.


BIOSIMILARS - Impact of Variability in Manufacturing Process

March | 2014
  • Presenter: Janmeet Anant, Regulatory Affairs Advocate, Merck
  • Abstract
    There is an impending potential growth in the development and manufacturing of biosimilars, relying on the regulatory landscape of the much more complex biologics drug products versus their simple chemical counterparts. Biotechnology products are highly complex and even subtle variations, often resulting from manufacturing changes, can negatively affect their safety and efficacy profile. This is the concern of regulatory bodies around the world. The European Medicines Agency (EMA) was the first to utilize the regulatory concept of comparability to biosimilars, while the US FDA has lagged behind with regulatory guidance until recently. On the other hand, the Asia market, particularly China and India, has seen a tremendous growth in biosimilar approvals in recent years, based on less stringent regulatory requirements.

    Biosimilar manufacturers must rely on expertise regarding the manufacturing process to understand which process parameters are critical in affecting process or product variability, as well as how to control that variability. Otherwise, sophisticated and more detailed protein structure and function studies are required, along with clinical studies to verify the protein is not altered slightly to affect immunogenicity.

    This presentation will cover the following:
    1. What are biosimilars and how do they compare to generics?
    2. What are the industry drivers and obstacles?
    3. What are the regulatory aspects of biosimilars and how do they vary based on regional regulatory bodies?
    4. How can a supplier's products, services and expertise be leveraged by sponsors involved with the development and manufacturing of biosimilars?